An observational study in Urinary Bladder, Overactive, Prostatic Hyperplasia, Benign and Bladder Outlet Obstruction, sponsored by Taksim Egitim ve Arastirma Hastanesi. Active, not recruiting at 1 site in Turkey (Türkiye). Open to male participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-04-28.
Sponsored by Taksim Egitim ve Arastirma Hastanesi · Observational
Intravesical OnabotulinumtoxinA (BoNT-A) injection performed concurrently with endoscopic prostate surgery provides superior clinical improvement at the 12th postoperative week compared to standard medical therapy in patients with urodynamically confirmed bladder outlet obstruction (BOO) and concomitant overactive bladder (OAB). This superiority is demonstrated through significant improvements in OABSS, OAB-V8, ICIQ-UI SF, IIQ-7, and IPSS scores.
Study Design and Patient Selection:
This prospective, randomized controlled study aims to evaluate the clinical efficacy of intravesical OnabotulinumtoxinA (BoNT-A) injection when performed concurrently with endoscopic prostate surgery (TURP or Laser Enucleation). Patients diagnosed with concomitant Bladder Outlet Obstruction (BOO) and Overactive Bladder (OAB) via preoperative urodynamic studies will be included in the study.
Intervention and Procedure:
Participants will be randomized into two groups:
Data Collection and Follow-up:
Baseline clinical data, including International Prostate Symptom Score (IPSS), Overactive Bladder Symptom Score (OABSS), OAB-V8, International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF), and Incontinence Impact Questionnaire-7 (IIQ-7), will be recorded preoperatively.
All patients will be followed for 12 weeks postoperatively. The primary objective is to compare the 12th-week clinical outcomes between the BoNT-A group and the standard medical therapy group. Statistical analysis will be performed to determine if simultaneous BoNT-A administration provides a significant advantage in alleviating OAB symptoms and improving quality of life in the early postoperative period.
858 studies on the registry are indexed under Urinary Bladder, Overactive; 127 are open to participants now.
This study's planned enrollment of 70 is below the median of 120 across 169 observational studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →Taksim Egitim ve Arastirma Hastanesi is the lead sponsor of 10 studies on the registry; 4 are open to participants now.
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"The study population consists of male patients who were treated at Taksim Egitim Ve Arastırma Hastanesi Urology Department. The cohort includes patients who underwent endoscopic prostate surgery for Benign Prostatic Hyperplasia (BPH) and had documented preoperative symptoms of Overactive Bladder (OAB). Data were retrospectively collected from the electronic medical records and patient charts of individuals treated between [2024] and [2027]."
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Neurological Pathologies:
Metabolic and Systemic Diseases:
Urinary System Related Pathologies:
Cardiovascular Risks ( for Mirabegron and Anticholinergics):
Other Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who received intravesical OnabotulinumtoxinA injection (100 Units) concurrently with endoscopic prostate surgery
Patients who underwent endoscopic prostate surgery and received standard postoperative medical therapy (anticholinergics or Beta-3 agonists) without BoNT-A injection
Change in Overactive Bladder Symptom Score (OABSS)
A validated questionnaire used to quantify overactive bladder symptoms. Total score ranges from 0 to 15, where higher scores indicate more severe symptoms
Time frame: Baseline (Preoperative) and Postoperative 12th Week
IPSS Score Change
International Prostate Symptom Score (0-35 points). Higher scores indicate more severe LUTS
Time frame: Baseline and 12th Week
Plan to share: No — Individual participant data will not be shared to protect patient privacy and maintain confidentiality in accordance with the institutional ethics committee regulations.
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Taksim Egitim ve Arastirma Hastanesi